New Delhi : The Ministry of Health and Family Welfare has issued a draft notification proposing amendments to the Medical Devices Rules, 2017, with an aim to simplify and speed up the licensing process for medical devices without compromising quality, safety and performance standards.
The proposed changes are intended to improve regulatory efficiency, promote ease of doing business and ensure quicker availability of quality medical devices in the country.
Faster Approvals for Medical Device Manufacturers
Under the existing Medical Devices Rules, medical devices are classified into four risk categories—Class A, Class B, Class C and Class D, with Class D covering the highest-risk devices. The draft amendments seek to shorten the approval timelines for manufacturing licences across these categories while retaining existing regulatory safeguards.
For Class B medical devices, which include products such as blood pressure monitors, hypodermic needles and pulse oximeters, the proposed licensing period has been reduced from 140 days to 115 days.
Similarly, the approval timeline for Class C and Class D devices, including cardiac stents, hip and knee implants and other orthopaedic implants, is proposed to be reduced from 105 days to 90 days.
Defined Timelines for Every Stage
The draft amendments also introduce fixed timelines for each stage of the licensing process, including application scrutiny, audits by notified bodies, compliance verification and issuance of licences.
According to the Ministry, these changes are expected to make the regulatory system more transparent, predictable and efficient, while helping manufacturers obtain approvals faster and enabling patients to access quality-assured medical devices sooner.
Public Consultation Invited
The draft notification has been published in the Official Gazette and placed in the public domain for feedback from stakeholders.
The Ministry has invited industry representatives, healthcare professionals and other stakeholders to submit their comments and suggestions within the prescribed consultation period before the amendments are finalised. The draft notification is also available on the website of the Central Drugs Standard Control Organisation (CDSCO).